Weaning protocol for high-flow nasal oxygen therapy in the ICU - Multicenter randomized controlled trial. HiFloWEAN

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

17 Feb 2024 → ongoing

Decision date (initial)

2023-09-19

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To show that the use of a protocol for weaning patients from High-Flow Nasal Oxygen Therapy increases the probability that patients will be weaned from High-Flow Nasal Oxygen Therapy at D7 post-randomization.

Secondary objectives 7

1. To show that the use of a high-flow nasal oxygen weaning protocol increases the probability that the patient will be weaned from high-flow nasal oxygen therapy at D28 post-randomization.
2. Compare the incidence of intubation, use of curative non-invasive ventilation or death up to D28.
3. Describe the duration of use of high-flow nasal oxygen therapy in patients weaned from high-flow nasal oxygen therapy
4. Study the evolution of the ROX index during the weaning phase
5. Study the evolution of accessory respiratory muscle activation and dyspnea during the weaning phase
6. Compare length of stay in intensive care and/or continuous care units
7. ntensive care unit and/or continuous monitoring unit and the discharge from the intensive care unit OR the ability to be discharged from the intensive care unit

Conditions and MedDRA coding

de novo acute respiratory failure

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Major patient (≥18 years old) admitted to the ICU or intensive care unit for acute hypoxemic respiratory failure de novo (with a PaO2/FiO2 ratio <300 mmHg).
2. Treated with high-flow nasal oxygen therapy with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, at inclusion
3. With ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88 (the patient must not be in a worsening phase).
4. Having had a gas measurement under high-flow nasal oxygen therapy within 24 hours of inclusion
5. Patient affiliated to a social security scheme
6. Written consent signed by the patient (by the designated person of trust, a parent, or a close relative in case the patient is incapacitated; this consent must subsequently be confirmed by the patient as soon as they are able to do so)
7. Treated with high-flow nasal oxygen in an intensive care unit or continuous care unit

Exclusion criteria 14

1. Presence of a patient included in the study and not weaned from high-flow nasal oxygen therapy in the area cared for by the patient's nurse assessed for eligibility
2. Individual deprived of liberty by a judicial or administrative decision, person hospitalized without consent, and person admitted to a healthcare or social facility for purposes other than research
3. Minor
4. Adult person subject to a legal protection measure (guardianship, curatorship, person under judicial protection)
5. Concomitant non-invasive ventilation treatment (if non-invasive ventilation is weaned for at least 12 hours and high-flow nasal oxygen therapy is still in progress, the patient will be eligible for inclusion)
6. Use of high-flow nasal oxygen therapy within 7 days of extubation
7. Chronic obstructive pulmonary disease (Gold grade 3 or 4)
8. Acute cardiogenic pulmonary edema as the primary cause of acute respiratory failure.
9. Diffuse interstitial lung disease as a medical history
10. Patients with long-term bi-level non-invasive ventilation
11. Patients on long-term home oxygen therapy
12. Pregnant woman, parturient mother, and breast-feeding mother
13. Patient with a medical decision not to intubate
14. Patients already included in the study, neither on the same hospitalization if they were to meet the inclusion criteria again, nor on subsequent hospitalizations.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint was the success rate at D7, with success defined as "definitive" weaning from high-flow nasal oxygen therapy, i.e. patients weaned for more than 48 hours from high-flow nasal oxygen therapy without recourse to non-invasive ventilation or intubation and alive at D7.

Secondary endpoints 11

1. Weaning rate from high-flow nasal oxygen therapy at D28
2. Time to definitive weaning from high-flow nasal oxygen therapy between randomization and D28
3. Cumulative incidence of intubation up to D28
4. Cumulative incidence of curative non-invasive ventilation up to D28
5. Mortality rate at D28
6. Number of days on high-flow nasal oxygen therapy in patients permanently weaned from high-flow nasal oxygen therapy between randomization and discharge from intensive care or at D28
7. Evolution of ROX index during weaning phase
8. Evolution of accessory respiratory muscle engagement by Patrick score
9. Progression of dyspnoea assessed by the modified Borg scale
10. Length of stay in intensive care and/or continuous care unit
11. Duration of stay between admission to the intensive care and/or continuous monitoring unit and discharge from intensive care OR the ability to be discharged from intensive care assessed through an aptitude assessment grid. The ability to be discharged from intensive care/continuous monitoring will be defined by the validation of all items on the modified aptitude assessment grid (see appendix).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire De Tours

Sponsor organisation

Centre Hospitalier Regional Universitaire De Tours

Address

2 Boulevard Tonnelle

City

Tours Cedex 9

Postcode

37044

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

Marie LECLERC

Public contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

Marie LECLERC

Third parties 1

Locations

1 EU/EEA country · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications